Responsible for setting the strategy for and the implementation of R&D Gx. P learning programs that align with business objectives and enhance BioPharma Clin. Ops capabilities. Define, develop, deploy and monitor the GCP policies and standards and execution for Gx. P training and capability in compliance with global regulatory and health authorities. Develop and maintain a strong trusted advisor relationship with BioPharma Clin. Ops Leadership, the Heads of R&D Learning, Global Talent Developmen... more details
At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We're passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new ideas to life.
As Director, R&D GxP Learning/ClinOps Learning for the R&D BioPharma Clinical Operations Process, Quality & Transformation & Learning function, you will play a pivotal role in shaping and delivering the clinical learning strategy for R&D and implement key GxP learning programs. This includes the development and implementation of innovative and comprehensive GxP learning strategies to meet the evolving needs of our internal staff, business partners, and clients globally, while ensuring compliance with Good Practices (GxP) guidelines and regulations. This experienced professional will contribute to making AZ a great place to work and be able to drive tangible business outcomes that demonstrate the impact of clinical learning to the organisation.
Key Responsibilities:
Responsible for setting the strategy for and the implementation of R&D GxP learning programs that align with business objectives and enhance BioPharma ClinOps capabilities
Define, develop, deploy and monitor the GCP policies and standards and execution for GxP training and capability in compliance with global regulatory and health authorities.
Develop and maintain a strong trusted advisor relationship with BioPharma ClinOps Leadership, the Heads of R&D Learning, Global Talent Development, and Global Learning Shared Services to ensure GxP learning strategies and programs fulfill business requirements
Lead and partner with IT and R&D L&D to identify and integrate new technology for the content creation and delivery of ‘right for role and task’ GxP training and capability. Develop measures and analytics to help assess the effectiveness of training and work instruction/training related to capability
Represents R&D on cross-functional and cross SET teams and steering committees related to GxP Learning, such as enterprise learning advisory board, R&D process governance board, and AZ mandatory training committee. Lead a team of GxP Learning professionals to execute the GxP learning strategy and prioritized opportunities.
Oversee Learning Academies and LMS Job definitions, which include strategic and GxP-focused learning plans/pathways for all functional, technical, professional development, new hire induction, and GxP content across the GxP areas of R&D
Serve as the Business Process Area Lead for R&D training
Oversee the coordination of existing and relevant content to support these strategic learning pathways and plans
Guide the R&D GxP Learning team on content curation, development, and lifecycle management to ensure ongoing relevancy and effectiveness of learning programs
Identify and leverage opportunities to standardize and simplify GxP and non-GxP Learning & Development processes and systems, driving efficiency and effectiveness
Oversee and implement communications and change activities relating to the GxP Learning strategy, ensuring effective messaging and alignment with strategic objectives
Design and implement the appropriate operating model and governance to deliver the R&D GxP Learning strategy
Conduct regular 'voice of employees' listening exercises, reviewing learning activity metrics to ensure that learning interventions deliver the agreed R&D business outcomes and a positive employee experience
Provide strategic oversight of vendor management for R&D-specific GxP learning content, ensuring alignment with our strategic learning programs
Education, Skills, and Experience:
BS/BA degree plus 10 years industry experience required; advanced degree preferred.
Minimum of 5 years of experience in clinical trial processes, GCP
regulations, guidance, and associated Quality Management Systems
Higher-level qualifications or accreditations in learning & development related field (preferred) and/or a proven track record of development and delivery of learning and development solutions in a Pharmaceutical R&D environment
Solid understanding of Adult Learning Principles, Learning Needs Analysis, Instructional Design and Development, and Design Thinking
Experience with the R&D drug development life cycle, specific experience with clinical operations (preferred), working in a highly regulated environment, and an understanding of the learning styles and needs of the R&D professional
Strong collaboration skills and ability to work in a matrix environment and influence others without authority
Ability to lead and manage complex learning projects that require more than one deliverable and handle multiple projects to successful completion
Delivery and outcome-focused, with the ability to set and manage priorities, resources, and goals for complex, fast-paced projects
Problem-solving skills; able to conduct root cause analysis and apply critical/analytical thinking to identify the most appropriate solutions to drive business performance
Excellent communication and facilitation skills
Strong relationship-building, resourcefulness, and organizational skills
Experience working in a global organization, across countries, cultures, and time zones
Able to quickly adapt to a continuously evolving business and learning landscape
Join our team in shaping the future at AstraZeneca and help us make a meaningful impact on patients' lives. Apply now to be part of our ambitious, innovative, diverse, and collaborative team.
Date Posted
15-May-2024
Closing Date
04-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.